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Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant

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ClinicalTrials.gov Identifier: NCT02658357
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Braeburn Pharmaceuticals

Brief Summary:
The study will be a 6-month, open-label, multiple center study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizo-affective Disorder Drug: Risperidone Implant Phase 2

Detailed Description:

The study will be a 6-month, open-label, study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.

Subjects who are diagnosed with schizophrenia or schizoaffective disorder according to DSM-V and are stable on a daily 4 mg oral dose of Risperidone for at least 8 weeks will be recruited into the study.

Subjects stable on a 4 mg oral dose of Risperidone will be implanted with two or three, 300 mg, Risperidone Implants. All implants will be placed in the inner aspect of the upper arm. Plasma concentrations of Risperidone and the active moiety will be measured prior to placement of the Risperidone Implants, throughout the implantation period, and after re-converting to oral Risperidone following the removal of the Risperidone Implants.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
Actual Study Start Date : October 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: 600 mg
Two, 300 mg Risperidone Implants
Drug: Risperidone Implant
Experimental: 900 mg
Three, 300 mg Risperidone Implants
Drug: Risperidone Implant



Primary Outcome Measures :
  1. Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone [ Time Frame: 6 months ]
  2. Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject (and/or a subject's authorized legal representative) has provided written informed consent
  2. Patient meets the following criteria:

    • Outpatient status
    • PANSS Total Score ≤ 80 at screening and if PANSS score at baseline is ≥ 20% change from screening, the patients cannot participate in the study.
    • A score of ≤ 3 on the following PANSS items:

      • Conceptual disorganization
      • Suspiciousness
      • Hallucinatory behavior
      • Unusual thought content
  3. Subject is male or female between 18 to 60 years of age
  4. Subject has a diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria

Exclusion Criteria:

  1. Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator
  2. Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide
  3. Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening.
  4. Have impaired hepatic (ALT/AST >1.5 times higher than the upper limit of normal) or renal function (eGFR<50 mL/min)
  5. Previously defined hypersensitivity to Risperidone
  6. History of neuromalignant syndrome (NMS)
  7. Electroconvulsive therapy within 6 months of admission
  8. Requires current use of agents that are strong inhibitors and inducers of cytochrome P450 2D6

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658357


Locations
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United States, Florida
Segal Institute for Clinical Research 1201 North 37th Avenue
Hollywood, Florida, United States, 33021
Sponsors and Collaborators
Braeburn Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Braeburn Pharmaceuticals:
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Responsible Party: Braeburn Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02658357    
Other Study ID Numbers: BB-PK-103
First Posted: January 18, 2016    Key Record Dates
Results First Posted: February 19, 2020
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Schizophrenia
Mood Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents